RCMF Process Supervisor New

RCMF Process Supervisor

Role Summary

The Ringaskiddy Clinical Manufacturing Facility (RCMF) is a new building on the

Ringaskiddy API site. It is a multi-product clinical API manufacturing facility enabled for

both traditional batch synthesis and continuous manufacturing via our new modular FAST

platforms. The facility design is focused on combining existing capabilities from our

clinical workflows with the very best advances in technology and architecture to build a

truly contemporary API clinical facility, which will support the needs of our new products

small molecule portfolio into the future. The RCMF is part of Chemical Research &

Development (CRD) and will scale up new clinical products developed in our CRD

laboratories at our research sites and will tech transfer successful candidates from the

RCMF to our commercial manufacturing plants.

The Process Supervisor is a key member of a dynamic, highly competent, engaged team of

colleagues responsible for delivering on our Production Schedule with excellent

performance across the fundamentals of safety, quality, supply, and cost.

The Process Supervisors take end to end ownership of our clinical API manufacturing

programs. They interface with the R&D project teams and oversee all aspects of the

technical transfer, from early engagement, right through start-up, manufacturing, and

delivery. The Process Supervisors play a key part in clinical process development and

subsequent commercial launch.

The Process Supervisor team are committed to continuous improvement, technical upskilling and personal development in a performance-driven environment. Production

Supervisors may be required to travel periodically to observe new processes in

transferring facilities; attend, contribute to and present at on and off-site meetings as

required.

The accountabilities of the Process Supervisor position include:

• Technical transfer of processes from R&D laboratories and the Kilo Lab into the

RCMF manufacturing facility (batch & continuous).

• Generation of optimal process fits/equipment configurations to meet process

needs.

• Understanding and use of manufacturing control systems to generate and execute

processing steps.

• Troubleshooting plant batch and continuous manufacturing operations.

• Clinical process development.

• Participation in co-development, launch and technical transfer of processes from

the RCMF to the commercial manufacturing organisation (PGS).

• Partner with Quality Operation, Analytical R&D, Logistics, Global Materials

Management, Engineering, and other partner functional lines.

• Development of procedures, training, manufacturing, and cleaning records and

other documentation as required to facilitate cGMP manufacturing.

• Participate in Continuous Improvement (CI) initiatives. Deliver efficiencies and

speed to market for new product introductions.

• Flawless RCMF manufacturing execution against safety, quality and customer

service metrics for clinical campaigns conducted within the facility.

• Monitoring and optimizing the quality and yield of the products including

optimization of the process with regard to efficiency, quality and safety.

• Real-time analysis of data (e.g. Process Analytical Technology data) and real-time

decision-making in partnership with Pharm Sci colleagues.

• Collection of data, trending, and generation of technical reports.

• Leading post-campaign reviews with Pharm Sci colleagues.

• Participating in cross-functional teams leading to accomplishment of RCMF goals.

• Partner with analytical colleagues to ensure effective integrated process analytics

and control.

• Provide support for digital initiatives and new technologies.

• Lead and supporting investigations and resolution of issues that may occur on

plant.

• Completion of personal training in compliance with procedures as part of a

comprehensive learning and development program.

• Providing training and support to new staff members of the RCMF team to ensure

that learning objectives are met.

• Maintain readiness for and participate in routine safety inspections, regulatory

inspections, and audits.

• Coordination of process equipment mechanical and electrical preps for processing.

• Additional areas of responsibility as the business requires.

Qualifications/Skills, Knowledge, Experience & Competencies:

• It is expected that the successful candidate be qualified to at least B.Sc. level in

chemistry or engineering with at least 3-5 years relevant experience in commercial

or clinical API small molecule manufacturing, and new product start-up / tech

transfer.

• Continuous manufacturing experience is not necessary but would be

advantageous.

• Excellent technical, problem-solving and communication skills.

• Focus on flawless execution and flexibility to get the job done.

• Comfortable as part of a highly competent and self-motivated team, and with an

ability to deal with the challenges that a new start-up and cutting-edge facility may

present.

• Demonstrated evidence of high performance in a continuous improvementoriented work environment.

• Excellent interpersonal skills, team orientation and attention to detail.

• Facilitation of an environment of open and team-based communication where all

members of the team work together to ensure that business targets are met.

• Strong ability to lead, challenge and positively influence in an interactive team

environment.

• Demonstrated ability to work on own initiative and proactively respond to business needs.